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NCT05814146
Trial of Variable Dialysate Bicarbonate
Conditions: Peri-dialytic Cardiac Rhythms, Intradialytic Hypotension, Electrolyte Changes, pH Changes, Adverse Symptoms
Sex: All
Ages: 18 Years – 120 Years
Healthy volunteers: No
Phase: NA
Enrollment: 141
Sponsor: Brigham and Women's Hospital
Location: Brigham and Women's Hospital Boston Massachusetts
Summary
QTc prolongation and premature ventricular contractions (PVCs) are common in hemodialysis (HD) patients and are associated with sudden cardiac death.
It is known that higher dialysate bicarbonate is associated with more QTc prolongation during HD sessions.
This study aims to assess the effects of lower (30 mEq/L) versus higher (35 mEq/L) dialysate bicarbonate in adult maintenance HD patients admitted to the hospital.
The investigators will randomly assign subjects to lower versus higher dialysate bicarbonate concentrations during their hospital stay for up to a maximum of six HD sessions or until their hospital discharge.
Eligibility Criteria
Inclusion Criteria:
* prevalent end-stage renal disease, on maintenance HD \> 90 days
* age ≥ 18 years old
* thrice weekly HD
Exclusion Criteria:
* hemoglobin \< 8.0 g/dL
* pregnancy
* any physical, mental or medical condition which limited the ability to provide written informed consent
Source: ClinicalTrials.gov (NCT05814146). StuddyBuddy aggregates publicly available trial information.
